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PresbyopiaPhase 3GEMINI 2NCT03857542

A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

A Phase 3 study testing Pilocarpine HCl Ophthalmic Solution in people with Presbyopia, run by Allergan at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with… Read more about this study

Who is it for?
Ages 40 to 55 years
Conditions the study is for
Presbyopia
What is being tested?
Pilocarpine HCl Ophthalmic Solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
427 participants
Where
35 sitesUnited States
Study dates
1 Mar 2019to 10 Sep 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjective complaints of poor near vision that impact activities of daily living

Who cannot join

  • Uncontrolled systemic disease
  • Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of AGN-190584. History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. However, participants with history of photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK) with corrected distance visual acuity (CDVA) meeting inclusion criteria will be allowed to enroll.
  • Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications
  • Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study
  • Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Show all 16Show fewer
  • Participation in a blood or plasma donation program within 30 days prior to study intervention administration
  • Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of > 33) at the screening visit
  • Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity
  • Narrow iridocorneal angles (Shaffer grade ≤ 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
  • History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria > 1 mm between pupils under mesopic conditions at the screening visit
  • Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy
  • Diagnosis of any type of glaucoma or ocular hypertension
  • Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled
  • Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history
  • Females who are pregnant, nursing, or planning a pregnancy during the study

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Keystone Research ltd. at Texan Eye

    Austin, Texas, 78731

  • Milton M. Hom, OD, FAAO

    Azusa, California, 91702

  • Chu Laser Eye Institute

    Bloomington, Minnesota, 55420

  • Benjamin Knox Lambright, MD

    Crystal River, Florida, 34429

  • The Midwest Center for Sight

    Des Plaines, Illinois, 60016

  • Eye Center South

    Dothan, Alabama, 36301

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017

  • The Cataract and Glaucoma Center

    El Paso, Texas, 79902

  • Vision Consultants and Surgeons

    Falls Church, Virginia, 22046

  • South Florida Vision Center

    Fort Lauderdale, Florida, 33309

  • Global Research Management

    Glendale, California, 91204

  • Texas Eye & Laser Ctr

    Hurst, Texas, 76054

  • Bowden Eye Associates

    Jacksonville, Florida, 32256

  • Silverstein Eye Centers

    Kansas City, Missouri, 64133

  • Moyes Eye Center

    Kansas City, Missouri, 64154

  • Jacksoneye

    Lake Villa, Illinois, 60046

  • Amel Youssef, OD

    Las Vegas, Nevada, 89117

  • Debry Medical Services PC

    Las Vegas, Nevada, 89128

  • Corneal Consultants of Colorado

    Littleton, Colorado, 80120

  • Advanced Vision Care

    Los Angeles, California, 90067

  • University Eye Surgeons

    Maryville, Tennessee, 37803

  • Total Eye Care, PA

    Memphis, Tennessee, 38119

  • North Valley Eye Medical Group, Inc.

    Mission Hills, California, 91345

  • Clayton Eye Center

    Morrow, Georgia, 30260

  • Mid Florida Eye Center

    Mt. Dora, Florida, 32757

  • Waring Vision Institute

    Mt. Pleasant, South Carolina, 29464

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Benjamin Travis Dastrup, MD

    Ogden, Utah, 84403

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • M&M Eye Institute

    Prescott, Arizona, 86301

  • Newsom Eye & Laser Center

    Sebring, Florida, 33870

  • Heart of America Eyecare

    Shawnee Mission, Kansas, 66204

  • Tekwani Vision Center

    St Louis, Missouri, 63128

  • Walman Eye Center

    Sun City, Arizona, 85351

  • Bucci Laser Vision

    Wilkes-Barre, Pennsylvania, 18702

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia

This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.

Conditions
Presbyopia
Being tested
Pilocarpine HCl Ophthalmic Solution, Vehicle
Medical subject headings
Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pilocarpine HCl Ophthalmic SolutionDrug

    Also called AGN-190584, VUITY

    Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.

  • VehicleOther

    Vehicle, one drop in each eye, once daily, for up to 30 days.

Study groups in NCT03857542
Study groupRoleWhat they receive
VehiclePlacebo comparatorParticipants received one drop of vehicle in each eye, once daily, for up to 30 days.
Receives: Other: Vehicle
Pilocarpine HCl Ophthalmic SolutionExperimentalParticipants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Receives: Drug: Pilocarpine HCl Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA, Without Losing More Than 5 Letters of Mesopic, High-Contrast, Binocular CDVA With the Same Refractive Correction at Day 30, Hour 3

    Visual acuity for near (40 centimeter (cm)) and distance (4 meter (m)) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions measured at the target. Forced choice letter by-letter scoring was used for each test and the total number of correct letters or the highest value (number) of the grid identified (as applicable) were recorded. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m^2) measured at the target. DCNVA= distance-corrected near visual acuity.

    Measured: Baseline (Day 1) to Day 30 (Hour 3)

Secondary outcomes (12)

  1. Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA at Day 30, Hour 6

    Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2 measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.

    Measured: Baseline (Day 1) to Day 30 (Hour 6)

  2. Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8

    Visual acuity for near (40 cm) was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2 measured at the target. Baseline for efficacy was defined as the last non-missing efficacy assessment before the first dose of study intervention. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.

    Measured: Baseline (Day 1) to Day 30 (Hour 8)

  3. Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5

    Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as lighting 3.2 to 3.5 cd/m^2 measured at the target. Mixed effect model for repeated measures (MMRM) was used for the analysis.

    Measured: Baseline (Day 1) to Day 30 (Hour 0.5)

  4. Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular DCNVA at Day 30, Hour 1

    Visual acuity for near (40 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target.

    Measured: Day 30 (Hour 1)

  5. Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3

    NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from a newspaper article, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rated as 0=I could not read any text due to problems seeing up close,1=poor,2=fair,3=good,4=very good,5=excellent; impact of squinting as 0=No,I did not squint, 1=Yes, squinting helped me read some/all text, 2=Yes,but I still could not read any of the text; and satisfaction as 0=very dissatisfied to 4=very satisfied. The score based on vision-related ability and impact of squinting=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses), total possible score of 0-5. Higher scores=better outcomes;positive change from Baseline=improved performance (reading ability).

    Measured: Baseline (Day 1) to Day 30 (Hour 3)

  6. Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3

    Visual acuity for intermediate (66 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target. MMRM was used for the analysis.

    Measured: Baseline (Day 1) to Day 30 (Hour 3)

  7. Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10

    Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast, binocular DCNVA are reported.

    Measured: Baseline (Day 1) to Day 30 (Hour 10)

  8. Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25

    Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2 measured at the target. MMRM was used for the analysis.

    Measured: Baseline (Day 1) to Day 30 (Hour 0.25)

  9. Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3

    Visual acuity for near (40 cm) targets was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target.

    Measured: Day 30 (Hour 3)

  10. Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3

    NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from a newspaper article, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, related as 0=I could not read any text due to problems seeing up close,1=poor,2=fair,3=good,4=very good,5=excellent; impact of squinting as 0=No, I did not squint, 1=Yes, squinting helped me read some/all text, 2=Yes, but I still could not read any of the text; and satisfaction as 0=very dissatisfied to 4=very satisfied. NVPTQ Satisfaction Score=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses)based on satisfaction items for a total possible score of 0 to 4. Higher scores=better outcomes; a positive change from Baseline indicates higher satisfaction.

    Measured: Baseline (Day 1) to Day 30 (Hour 3)

  11. Mean Change From Baseline in Presbyopia Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3

    PICQ=20 questions about impact experienced by participants due to their problems over past 7 days.PICQ Coping domain had 8 items: 1:Normal-sized text,2:Small-sized text,3:Information on a computer,4:Information on a cell phone,5:Increase font size,6:Use glasses to read close,12:Hold reading materials farther out/closer,13:Squint to read. Each item had response categories:0=never to 4=all the time. Items 3, 4, 5, and 6 had additional response categories with values of 9/10 to indicate the question is not applicable to participant and were assigned missing values.PICQ Coping Score:(Item 1,2 Testlet+Item 3,4 Testlet+Item 5+Item 6+Item 12+Item 13)/non-missing responses to the 6 components of coping score where Items 1,2 Testlet=(Item1+Item2)/non-missing responses to Items 1,2;Items 3,4 Testlet=(Item3+Item4)/non-missing responses to Items 3, 4. Score ranges:0=to least amount of coping to 4=greatest amount of coping. Higher scores=poorer outcome; a negative change from Baseline=improvement.

    Measured: Baseline (Day 1) to Day 30 (Hour 3)

  12. Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3

    PICQ had 20 questions about impact experienced by participants due to their problems seeing up over past 7 days. Impact domain of PICQ has 6 items:Item9:Rely on others,Item15:rest eyes,Item16:Feel older,Item17:Feel self-conscious,Item19:Take longer to complete task,Item20:Inconvenient.First 5 impacts items include response ranges from 0=never to 4=all of time. Item20 ranged from 0=Not at all,to 4=Extremely. Item9 included an additional response category, labeled with value of 9 to indicate question is not applicable because participant did not have opportunity to experience impact responses are assigned missing values. PICQ Impacts Score=[(Items 9+15+16\&17 Testlet+Item19+Item20)/(nonmissing responses to 5 components of impacts score)] where Items 16\&17 Testlet=(Items16+17)/non-missing responses to Items16 and 17. PICQ Impact score ranged 0-4, 0=least amount of impacts,4=greatest amount of impacts. Higher scores correspond to poorer outcomes; negative change from Baseline=improvement.

    Measured: Baseline (Day 1) to Day 30 (Hour 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2019
  2. Study start1 Mar 2019
  3. Primary completion10 Sep 2020
  4. Study completion10 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03857542
Sponsor's protocol ID
1883-302-013
Acronym
GEMINI 2
Status last verified
Nov 2021
First submitted
26 Feb 2019
Last updated
29 Dec 2021
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pilocarpine HCl Ophthalmic Solution in people with Presbyopia, run by Allergan at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA, Without Losing More Than 5 Letters of Mesopic, High-Contrast, Binocular CDVA With the Same Refractive Correction at Day 30, Hour 3 (time frame: Baseline (Day 1) to Day 30 (Hour 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857542.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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